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Measuring Transplant Outcomes by Collecting Data on Children Born to Uterus Recipients

Proposal Overview

Status: Public Comment

Sponsoring Committee: Vascularized Composite Allograft (VCA) Transplantation

Strategic Goal: Improve waitlisted patient, living donor, and transplant recipient outcomes

Read the request for feedback (PDF; 01/2020)

Contact: Tina Rhoades

eye iconAt a glance

What is current practice and why address it?

Uterus transplantation in the U.S. is rapidly growing. As such, the health of the recipient and post-transplant outcomes is a key concern to the OPTN and the transplant community. Currently, very little data about children born to women who have had a uterus transplant is reported to the OPTN, and only on a voluntary basis. In order to monitor post-transplant outcomes and the health of the recipient, feedback is requested to inform a future project about what data to report on children born to uterus transplant recipients.

What’s the concept?

  • To consider what, if any, additional, appropriate data that could be reported about children born to uterus transplant recipients:
    • At birth
    • As follow-up
  • Consider how long after birth should information be reported.
  • Identify any challenges a requirement to report additional information could present.

What this feedback could accomplish

  • Could help develop future data reporting requirements.

What this concept wouldn’t do

  • Collect unnecessary data on children born to uterus transplant recipients.
  • Mandate data collection at this time.

Terms you need to know

  • Vascularized Composite Allograft (VCA): Transplant of multiple structures, which may include connective tissue, skin, bone, muscles, blood vessels, and nerves.  For example, face and hand transplants are two of the most well-known types of VCA transplants.
  • Click here to search the OPTN glossary.

Comments

Baylor University Medical Center | 02/03/2020

We appreciate the opportunity to provide feedback on Measuring Transplant Outcomes by Collecting Data on Children Born to Uterus Recipients. Our center’s experience with uterus transplant for the past several years, including delivery of several healthy babies, puts us in a unique position to inform this work. Children born thus far, in our study and in Sweden, are on target for developmental milestones. In studies of delivery following solid organ transplant in immunosuppressed individuals it has been observed that there is a higher incidence of low birth weight infants and pre-term labor. Delivery following uterus transplantation is controlled and occurs prior to 40 weeks gestation. Infants born to recipients in our program and in Sweden have been of appropriate weight for gestational age and growth on par with expectations following delivery. We question the value of collecting information on healthy infants but can support follow up of children delivered after uterus transplantation for a maximum of 2 years, including only information gathered at routine pediatric visits. As with living donors and recipients, we educate our patients on the importance of and requirements for follow up. Even with those efforts, data collection may pose challenges if recipients are unwilling to share information directly or allow information to be shared by the pediatrician. We recognize the importance of monitoring of this novel type of VCA transplantation and look forwarding to continued collaboration with UNOS/ OPTN and other programs.

American Society for Reproductive Medicine | 03/17/2020

Under Executive summary (p2): The correct nomenclature is uterus transplant (See ASRM Guidelines). There have been now at least 9 children born from transplant in US (Baylor-6, Penn-1, CCF-2). Under Purpose (p3): "eight children"-this is a moving target, suggest "at least 9" p5: "prematurity, low birth weight, and birth defects"-Reference 5 is missing (do not see below)? I am not aware of data that shows the immunosuppressive regimens result in increased risk of birth defects unless medications contraindicated in pregnancy are used (i.e., MMF). p6, last paragraph: At this point, SRS/ASRM has developed a more comprehensive registry that includes IVF parameters, transplant, posttransplant , pregnancy, and post-pregnancy child and maternal data (up to 2 years of age for child and up to 2 years post-hysterectomy for mother). Note that SRS and SART are both affiliated societies within ASRM. "secure funding"-SRS initiative is complete and no funding issues exist P8, "...only entity that currently collects data on all the children..."-see previous comment. Not the only entity collecting data but the only entity that can require data collection true p9-Table 1: Are maternal characteristics that you are collecting listed in other places? I.e., indication for delivery--severe preeclampsia, elective, spontaneous preterm delivery, rupture of membranes etc. Need to know not only how far along but why they were delivered when they were delivered. Consider adding neonatal cord gas values; good snap shot of how baby was doing at delivery---pH, base excess, pCO2 "obstetric estimate of gestation"-All of these women get pregnant by IVF so there is no need to have a separate obstetric issue. The dating is known, gestational age is the data point you want. Consider ICU y/n and, if so, reason. May have a normal length of stay but need to be in ICU for some reason. Important to know. p10 "data collection past birth."-Strongly discourage this. Would recommend making it compulsory initially and if programs are having difficulty assessing where barriers are and addressing. Otherwise I suspect you will get many "lost to follow-ups" because this is hard. But given the goal of uterus transplantation is for these couples to have children, the health of the children is one of the most important outcomes and must be obtained. p10-Conclusion-Is there a separate form for follow-up of the recipient post delivery and post-hysterectomy? Assessing for long-term renal function, complications related to vasculature altered during the transplant (i.e., claudication?). p10, second bullet: Dr. Jennifer James to comment

NATCO | 03/23/2020

NATCO supports the collection of data to evaluate outcomes for children born to uterus recipients. The results can direct medical management to identify opportunities for improvement and optimize outcomes.

Transplant Pregnancy Registry International, a Division of Gift of Life Institute | 03/23/2020

We appreciate the opportunity to provide feedback on Measuring Transplant Outcomes by Collecting Data on Children Born to Uterus Recipients. Our organization, the Transplant Pregnancy Registry International (TPR) is a voluntary Registry that has been collecting outcomes on pregnancy after all types of solid-organ transplants since 1991. Included in the IRB approved TPR is the long-term follow-up of the offspring. There are offspring in the TPR who are parents, making the transplant recipient a grandparent. Interestingly, it is only because of the data gathered from the TPR, that there are immunosuppressant medications that are safe to take during pregnancy, making uterus transplantation now possible. The TPR reports that the birth defect rate for 1533 offspring born to kidney recipients is approximately 4.5% which is similar to that of the general population which ranges between 3-5%.(1) As of December 31, 2019 the TPR follows approximately 2,388 offspring born to 1,803 solid-organ transplant recipients. While we know that this does not represent all of the pregnancies that have occurred, it is the largest cohort reported. The TPR is dedicated to the study of pregnancy after transplant and is well established in the transplant community. The TPR is well-equipped to follow the uterine transplant recipient offspring and has built in comparison groups. We have found that transplant recipients are generous with their time and are more than willing to participate in a follow-up telephone call-especially if it will benefit future transplant recipients; we have been speaking with some since 1991. Also the uterine transplant offspring should not be compared to the general population, but to a similar cohort such as the kidney transplant recipient offspring who also had exposure to immunosuppression. It does not seem prudent to have a separate registry for uterine transplant offspring, when there is a mechanism already in place to follow these outcomes. Additionally, all VCA transplant recipients who require immunosuppression and their offspring are eligible to participate in the TPR. 1. Transplant Pregnancy Registry International (TPR) 2018 Annual Report, Gift of Life Institute, Philadelphia, PA 2019.

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) generally supports this policy, however we feel strongly that uterine transplant is an abdominal organ that should be considered separately under its own egis and not as a vascular allograft. Recipients of uterine transplants require unique considerations to address their specific needs including coordination with other medical specialties such as infertility medicine. When uterine transplants are performed, we recommend offspring are observed at the following intervals: birth to record APCAR score, 1 month to record early survivability and growth, 1 year, and 6 years to record physical and intellectual development. We also suggest the OPTN VCA Transplantation Committee seek legal and ethical guidance on concerns related to: HIPPA, collecting data on offspring as a non-transplant patient, and potential regulatory challenges. Guidance might be sought from legal entities and from the gynecological, obstetrics, and pediatric communities.

OPTN Ethics Committee | 03/23/2020

The Ethics Committee thanks the OPTN Vascularized Composite Allograft Transplant (VCA) Committee for their efforts in developing this public comment proposal for data collection of the children born to uterus transplant recipients. The Committee supports the idea of collecting these data in general, and the proposal raises some ethical concerns. The Committee recognizes the importance of data to inform patient safety and potential recipient informed consent, and acknowledges that a healthy child is the main metric for measuring the success of such a transplant. The Committee also recognizes that recipients may have concerns about providing consent for data collection over several years. Recipients may need to be re-consented over time. The Committee is concerned about balancing the need for these data and the ethically obtaining children’s assent. Additionally, Committee members pointed out that parents and children may feel a lack of “normalcy” or experience psychological distress from the act of monitoring. Several members of the Committee indicated that the requested monitoring would be similar to what is already required of transplant patients or any neonatal study and believed that it is common practice to acquire this level of consent. Lastly, committee members questioned if the proposed five-year follow-up would be difficult to mandate given logistical issues of recipients moving away during that time.

OPTN Living Donor Committee | 03/23/2020

The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this public comment item. Committee members encouraged the VCA Committee to consider incorporating information that is already collected by pediatricians so as not to duplicate information gathering.

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is generally supportive of this proposal and shares the following comments. • We recognize that VCA has yet to develop accepted standards to define outcomes and to define success. This limits the ability to interpret and compare outcomes from disparate groups, particularly considering the small number of patients being treated worldwide. • Uterus transplantation is experimental and as it becomes a more common procedure in the United States, there is a need for uniform reporting and evaluation of outcomes. The birth of a child is the desirable outcome of a uterus transplant. As such we support the collection of data on children born to uterus recipients as the outcome measure of the transplant. • The elements suggested in Table 1 are reasonable. • The length of stay (LOS) may not truly capture the information desired, such as LOS in NICU although it will capture a LOS that is longer than expected. • Although it may be desirable to collect data on the subsequent development of a child, it may not be ethical, and development may have may other confounding influences. If found to be ethical, to potentially minimize the data collection burden, consideration could be given to completion of data collection forms by the child’s legal guardian who would then return them to the transplant center for submission to the OPTN to address the complexities and high administrative burden of this type of data collection for the transplant program. • The risk for congenital infection will be increased in immunocompromised mothers. Accordingly, infants should be tested for congenital CMV and/or toxoplasma if the mother is positive. Going forward, consideration should be given to collection of this data on infants born to mothers with uterine transplant. • Admittedly the VCA Committee has enlisted the input of many stakeholders to date. Going forward it will be essential to continue to involve pediatricians, neonatologists, and ethicists.